First MPJ disorders treated with Botulinum Toxin

NewsBot · Oct 9, 2007

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This patent application was filed a couple of years ago, but has just been granted:
Methods of treating abnormalities of the first metatarsophalangeal joint of the foot

Disclosed is a method for treating abnormalities of the first metatarsophalangeal joint of the foot of a mammal comprising administering a therapeutically effective amount of neuromuscular toxin to the mammal. Preferred embodiments include administering toxins capable of interfering with the connection between muscle and nerve, e.g. botulinum toxin, to the patient to treat such abnormalities as hallux abductovalgus, hallux varus, hallux limitus, and hallux rigidus.
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Link to patent

Admin2 · Oct 9, 2007

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NewsBot · Dec 29, 2011

This clinical trial was just registered:

Effect of Botulinum Toxin to Hallux Valgus in Addition to Total Contact Insole

The investigators propose a new therapeutic approach by injecting Botulinum Toxin Type A (BTA) to the oblique and transverse heads of adductor muscle of the great toe. BTA works by binding presynaptically to high-affinity recognition sites on the cholinergic nerve terminals and decrease the release of acetylcholine, causing a neuromuscular blocking effect. The investigators hypothesize that BTA injection may help to decrease the hallux valgus angle by decrease adductor hallucis muscle activation. Thereby enhance the therapeutic result of hallux valgus treated with total contact insole. The outcome measurement may shed light in treating patient with painful hallux valgus and document evidence for plantar pressure changes in acute, sub-acute and chronic stage.
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NewsBot · Feb 18, 2015

Botulinum Toxin type A injections for patients with painful hallux valgus: a double-blind, randomized controlled study.
Wu KP et al
Clin Neurol Neurosurg. 2015 Feb;129S1:S58-S62. doi: 10.1016/S0303-8467(15)30014-7.

Hallux valgus (HV) related pain and disability remains a medical challenge to date. We have evaluated the therapeutic effect of intramuscular Botulinum Toxin type A (BTX-A) injection on painful HV in a double-blind randomized controlled trial. Sixteen patients having painful HV in at least one foot from the Department of Physical Medicine and Rehabilitation at a medical center in northern Taiwan have participated. Patients were randomized into two groups to receive intramuscular injections of either BTX-A or normal saline (NS) to the oblique and transverse heads of the adductor hallucis, flexor hallucis brevis and extensor hallucis longus muscles. Primary outcome measurements were selected from the Taiwan Chinese version of the Foot Function Index subscales on pain (questions 1-6, 9) and disability (question 10-18). The secondary outcome measurement was the HV angle. Patients were assessed at baseline and at 1, 2, 3, and 6 months after treatment. The demographic data and measurements were comparable between the two groups at baseline (p>0.05). BTX-A and NS reduced pain and disability one month after injection. Pain reduction induced by BTX-A injection lasted for at least 6 months while that induced by NS lasted for only 1 month. In addition, patients in the BTX-A group showed greater improvement in pain score (p<0.001), disability score (p<0.05), and HV angle (p<0.05) than patients in the NS group. The results reflected that HV-related muscle injection of BTX-A resulted in a marked reduction in pain for up to 6 months.
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NewsBot · Oct 22, 2016

Effective conservative treatment for managing Painful Hallux valgus
Simon Fuk Tan Tang, John Tzu-Ning Chen, Chih-Kuang Chen, Alice Chu-Wen Tang
Source

Hallux valgus (HV) is a foot disorder manifesting by lateral deviation of the great toe and medial deviation of the first metatarsal. HV not only affects foot appearance, but also causes functional disability, including foot pain, impaired gait patterns, balance disorders, which further lead to easily falling and impaired quality of life. It affects approximately 23% of adults, but so far effective conservative interventions are limited. Patients generally receive conservative treatments when having a mild (<30°) HV angle, including night splints, foot exercises, and orthotic application. But previous studies suggested that the effectiveness of orthotic devices and night splints were no superior to no treatment at all for mild-to-moderate HV patients. In recent studies, conservative treatment such as using foot insoles with fixed toe separator and managing with Botulinum toxin type A (BTA) could lead to sustained relief of symptoms. The procedure was less invasive than surgical intervention and relatively easy to perform.
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NewsBot · Jun 27, 2018

This clinical trial was just registered:
Dysport in Hallux Abducto Valgus (HAV) Phase IIa (DYSTANCE)

The purpose of this study is to investigate the efficacy and safety of treatment with multiple doses of Dysport in adults suffering from clinically significant pain associated with HAV who have not undergone surgery for their condition.
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NewsBot · Jun 21, 2020

Nonsurgical Treatment for Hallux Abducto Valgus With Botulinum Toxin Type A
Philip Andrew Radovic
J Am Podiatr Med Assoc. 2020 Mar 1;110(2)

Background: Hallux abducto valgus (HAV) is a frequently seen abnormality of the first metatarsophalangeal joint. Limited conservative treatment options exist, making surgery the only definitive treatment option for a mild to moderate deformity. Since initially published in 2008, treatment of HAV with botulinum toxin injection has evolved as a potentially effective modality as shown in several subsequent independent studies.

Methods: Botulinum injection of two intrinsic foot muscles (extensor halluces brevis and flexor hallucis brevis) in addition to adductor hallucis under electrical stimulation is presented as an improvement to the original method.

Results: The additional muscle injections of botulinum resulted in an further reduction of the HAV deformity and associated pain.

Conclusions: A significant improvement to the injection paradigm developed the author may prove to be more effective in reducing the HAV deformity and its associated pain.
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NewsBot · Jul 12, 2022

Pain Reduction With AbobotulinumtoxinA for the Treatment of Hallux Valgus in Adult Participants: Results of a Randomized and Placebo-Controlled Phase 2 Trial
David G. Armstrong, DPM, MD, PhD et al
July 11, 2022

AbobotulinumtoxinA (aboBoNT-A, Dysport®) inhibits acetylcholine release at the neuromuscular junction and may modulate pain signaling in hallux valgus (HV). This randomized study (NCT03569098) included a double-blind phase (aboBoNT-A 300U, 500U or placebo injections into forefoot muscles) and an open-label aboBoNT-A treatment period in participants with an HV diagnosis and no HV surgery. The primary endpoint was change from baseline in numeric pain rating scale (NPRS) score at week 8. Secondary endpoints included change in NPRS (other time points) and proportion of participants with ≥20% reduction from baseline NPRS (responders). Post-hoc analyses assessed number of days in a 7-day evaluation period that participants spent in a lower pain state than at baseline. Participants received aboBoNT-A 300U (n=63), 500U (n=60) or placebo (n=63). Superiority to placebo was not observed with either aboBoNT-A dose at week 8, thus the primary endpoint was unmet. At week 12, a trend toward efficacy was observed with aboBoNT-A 500U versus placebo and responder rates were greater with aboBoNT-A 500U versus placebo (p=0.006). Participants in the aboBoNT-A 500U group spent more days with lower NPRS than their lowest baseline score, and with NPRS ≥2 points lower than their mean baseline NPRS at weeks 8 and 12 versus placebo (all p<0.05; post-hoc). AboBoNT-A was well tolerated. Although the primary endpoint was unmet, other endpoints showed a nominal advantage for aboBoNT versus placebo for treatment of HV-related pain, particularly at week 12. Further clinical evaluation is needed to establish whether botulinum toxins represent a viable non-operative treatment option for HV-associated pain.
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NewsBot · Nov 6, 2022

Pain Reduction With AbobotulinumtoxinA for the Treatment of Hallux Valgus in Adult Participants: Results of a Randomized and Placebo-Controlled Phase 2 Trial
David G Armstrong et al
J Foot Ankle Surg. 2022 Jul 12

AbobotulinumtoxinA (aboBoNT-A, Dysport® [Ipsen, Paris, France]) inhibits acetylcholine release at the neuromuscular junction and may modulate pain signaling in hallux valgus (HV). This randomized study (NCT03569098) included a double-blind phase (aboBoNT-A 300U, 500U or placebo injections into forefoot muscles) and an open-label aboBoNT-A treatment period in participants with an HV diagnosis and no HV surgery. The primary endpoint was change from baseline in numeric pain rating scale (NPRS) score at week 8. Secondary endpoints included change in NPRS (other time points) and proportion of participants with ≥20% reduction from baseline NPRS (responders). Post-hoc analyses assessed number of days in a 7-day evaluation period that participants spent in a lower pain state than at baseline. Participants received aboBoNT-A 300U (n = 63), 500U (n = 60) or placebo (n = 63). Superiority to placebo was not observed with either aboBoNT-A dose at week 8, thus the primary endpoint was unmet. At week 12, a trend toward efficacy was observed with aboBoNT-A 500U versus placebo and the proportion of participants with ≥20% reduction from baseline NPRS was greater with aboBoNT-A 500U versus placebo (p = .006). Participants in the aboBoNT-A 500U group spent more days with lower NPRS than their lowest baseline score, and with NPRS ≥2 points lower than their mean baseline NPRS at weeks 8 and 12 versus placebo (all p < .05; post-hoc). AboBoNT-A was well tolerated. Although the primary endpoint was unmet, other endpoints showed a nominal advantage for aboBoNT versus placebo for treatment of HV-related pain, particularly at week 12. Further clinical evaluation is needed to establish whether botulinum toxins represent a viable non-operative treatment option for HV-associated pain. PLAIN LANGUAGE SUMMARY: Hallux valgus is the medical name for a bunion, a foot deformity that can worsen over time. Patients with bunions experience pain and walking can become difficult, which can affect their quality of life. Foot support aids (e.g., braces, splints and inserts) are available, but surgery is the standard treatment. This study looked at how injections of a specific type of botulinum toxin, called abobotulinumtoxinA or "aboBoNT-A", into the foot may help to reduce pain in patients with bunions. The study included 186 patients aged 18 to 75 years who had not had surgery on their bunion. The researchers looked at how well the injections worked using scales that measure the pain levels the patient experienced. The main outcome was whether patients who had aboBoNT-A injections had less pain after 8 weeks than they did before treatment. The study included patients who were injected with saltwater (no treatment) to check that any treatment effect was real. Researchers also looked at the results after 12 weeks, as well as how many patients had less pain after treatment than before and how many days in a given week patients experienced less pain after treatment than they did before. There was no reduction in pain levels with aboBoNT-A injections after 8 weeks compared with no treatment. However, the other study outcomes suggested that aboBoNT-A resulted in a small benefit compared with no treatment, especially after 12 weeks. Further medical research is needed to establish whether botulinum toxins represent an alternative treatment to surgery for the pain associated with bunions.
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NewsBot · Jan 24, 2023

Exploring the Relationship Between Clinical Presentation in Hallux Valgus and Response to AbobotulinumtoxinA Treatment
Babak Baravarian, DPM et al
January 18, 2023

The relationship between pain/disability and angular deviation of the hallux valgus (HV), and the impact of orthotic use, laterality, and pain variability on treatment outcomes remain unclear. This was explored in post hoc analyses of a placebo-controlled trial of abobotulinumtoxinA (aboBoNT-A; Dysport®) for HV-associated pain (NCT03569098). The primary endpoint was not met in this study (change from baseline Numeric Pain Rating Scale [NPRS] score vs placebo at week 8); however, there was a greater reduction from baseline in mean NPRS score at week 12 with aboBoNT-A 500U versus placebo (p = .06). Adults with painful HV without surgery were randomized (1:1:1) to aboBoNT-A 300U, aboBoNT-A 500U, or placebo. NPRS was completed for 7 days before baseline and weeks 4, 8, and 12. Over-the-counter orthoses were permitted. Participants (N = 186) had a mean [standard deviation, SD] age of 48.2 [13.1] years, 18% (33/186) used orthotics, and 67% (124/186) had bilateral HV. No associations between baseline pain severity and angular deviation were identified. Participants with high pain variability at baseline (SD >2) had a poorer response to aboBoNT-A treatment than those with less variability. In conclusion, no relationship between HV-related pain/disability and angular deviation was observed
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